ANDA 077856

PRINSTON INC

FDA Drug Application

Application #077856

Application Sponsors

ANDA 077856

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	0.5MG	0	CLONAZEPAM	CLONAZEPAM
002	TABLET;ORAL	1MG	0	CLONAZEPAM	CLONAZEPAM
003	TABLET;ORAL	2MG	0	CLONAZEPAM	CLONAZEPAM

FDA Submissions

	ORIG	1	AP	2006-06-28
LABELING; Labeling	SUPPL	2	AP	2007-07-09
LABELING; Labeling	SUPPL	3	AP	2009-10-21
LABELING; Labeling	SUPPL	5	AP	2011-09-15
REMS; REMS	SUPPL	8	AP	2012-06-20
LABELING; Labeling	SUPPL	11	AP	2016-02-10	STANDARD
LABELING; Labeling	SUPPL	18	AP	2016-07-18	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	15
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77856
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONAZEPAM","activeIngredients":"CLONAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONAZEPAM","submission":"CLONAZEPAM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)